Data Integrity is one of the basic GMP principles. Multiple Data Integrity citations were reported by FDA and European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been, and will, continue be the focus of many GMP inspections.
As a consequence international authorities – FDA, EMA, PIC/S, WHO, MHRA - published draft documents to describe the regulatory expectations of Data Integrity.
Although all guidelines are not intended to impose an additional regulatory burden to the regulated companies, a lot of uncertainty predominates the pharmaceutical industry as to how to implement these requirements into the daily business.
For information visit www.gmp-compliance.org